Senior Medical Writer

Contact: Alexandra Spink - aspink@penfieldsearch.com
No 3rd party candidates

Job Summary:
The Senior Medical Writer is a key member of the Clinical Operation organization responsible for independently authoring, managing, and delivering high-quality clinical documents for both prescription drugs and medical devices across all phases of development. In addition to hands-on writing, this role provides strategic input into clinical development and regulatory submissions, leads process improvements within Medical Writing, and supports global collaboration and onboarding where needed.

Key Responsibilities

• Author and manage the development of clinical and regulatory documents including protocols, protocol amendments, clinical study reports (CSRs), investigator brochures (IBs) / Reports of Prior Investigations (ROPIs), informed consent forms (ICFs), and labeling documents.
• Compile clinical documentation to support regulatory submissions and responses to questions from health authorities.
• Perform literature surveillance in relevant scientific fields; analyze and implement in clinical design; disseminate relevant information to the team.
• Collaborate cross-functionally with Biostatistics, Clinical Operations, medical Experts, Regulatory Affairs, and other functions to ensure scientific accuracy.
• Manage timelines for the development of clinical and regulatory documents including kickoff and comments resolution meeting.
• Document decisions made at kickoff meetings and comments resolution meeting
• Participate in study kickoff meetings, comment resolution discussions, and contribute to cross-functional planning.
• Provide project management oversight for writing deliverables across multiple programs, supporting timeline adherence, compliance, and quality expectations as needed.
• Perform and document quality control (QC) of internally and externally authored documents.
• File clinical and regulatory documents, as applicable, in the study TMF. Serve as member of the inspection readiness team in preparation of a regulatory inspection.
• Adapt quickly to urgent project needs, including rapid turnaround on protocol amendments or ad hoc deliverables.
• Ensure compliance with global regulatory requirements, ICH guidelines, ISO standard, GCP standards, and company SOPs.
• Participate in the development and improvement of working instructions and routines

Minimum Education, Knowledge, Skills, and Abilities

• PhD or PharmD in Life Sciences required, with a minimum of 5 years of relevant medical writing experience in clinical research.
• Demonstrated expertise in the pharmaceutical industry, with proven experience developing documentation to support regulatory and clinical needs.
• Extensive hands-on experience in authoring key clinical documents, particularly protocols and clinical study reports (CSRs).
• Strong understanding of ICH guidelines, GCP, and global regulatory frameworks (FDA, EMA, NMPA).
• Experience collaborating with cross-functional teams across multiple geographies and time zones (US, EU, China preferred); not expected to maintain availability outside of local working hours except for scheduled meetings.
• Excellent written and verbal communication skills, with a proven ability to collaborate across diverse teams, influence without authority, and work independently and flexibly in a fast-paced, evolving environment.
• Strong attention to detail and commitment to scientific rigor and regulatory compliance.
• Fluent in English (written and oral)